An interventional study of Protective "open-lung" extubation and Conventional extubation in Intra-abdominal Surgery, Anesthesia and Lung Injury, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment
Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective "open lung" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various "open lung" ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in "open lung" ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation.
Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications.
The aim of this study is to establish the feasibility of a multicenter randomized controlled clinical trial comparing two clinical strategies called "open lung" and "conventional" during extubation. The investigators also aim to estimate the rates of postoperative pulmonary complications in the two intervention groups.
METHODS
A multicenter internal pilot, prospective, randomized, allocation-concealed and controlled assessor-blinded study. Two hundred sixteen patients scheduled to undergo elective intra-abdominal surgery requiring general anesthesia and planned hospitalization at four Canadian hospitals, and at moderate or high risk of postoperative pulmonary complications according to the ARISCAT score will be recruited. Following the administration of standardized mechanical ventilation and after obtaining consent, participants will be randomly assigned to two groups:
Group A: Intervention group, "open lung" extubation strategy Group B: Control group, "conventional" extubation strategy.
The rate of adherence to the extubation protocol, the weekly patient recrutement rate and the 7-day postoperative pulmonary complications outcome completion rate will be measured. We will only report secondary efficacy outcome in aggregate as they will be rolled over to the definitive trial.
120 studies on the registry are indexed under Ventilator-Induced Lung Injury; 39 are open to participants now.
This study's planned enrollment of 270 is above the median of 40 across 74 interventional studies indexed under Ventilator-Induced Lung Injury.
Browse Ventilator-Induced Lung Injury studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
Compared within Ventilator-Induced Lung Injury, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Injury. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
At the beginning of emergence, patients will be positioned with the head of the bed elevated to at least 30 degrees and the FiO2 will be set at 50%. At the resumption of spontaneous ventilation or earlier at the discretion of the anesthesiologist, the ventilator will be set to pressure support ventilation mode for the rest of the emergence procedure. The pressure support level will be adjusted to obtain a volume similar to the one used prior to emergence. PEEP will be left unchanged. Anesthesiologists will be instructed not to switch off the ventilator until the patient is extubated.
Other: Protective "open-lung" extubation
At the beginning of emergence, patients will be positioned in a dorsal decubitus position and the FiO2 will be set at 100%. At the resumption of spontaneous ventilation or earlier at the discretion of the anesthesiologist, the ventilator will be switched off for the rest of the emergence procedure with the adjustable pressure-limiting valve open to atmosphere. Manual ventilation or assistance will be allowed, but the adjustable pressure-limiting valve will be reopened when pausing manual ventilation or assistance.
Other: Conventional extubation
Emergence using 50% FiO2, semi-sitting position with pressure support ventilation and preserved PEEP
Emergence using 100% FiO2, dorsal decubitus position with assistance or manual bag ventilation without PEEP
Average weekly patient recruitment rate
Achieve a weekly patient recruitment rate of 2 patients per week per center
Time frame: Every week. At the end of the study (average 9 months) at the study level.
Protocol adherence rate
Assess adherence to a protocol during emergence from anesthesia, monitoring four criteria (proper positioning (dorsal decubitus or semi-sitting position), correct FiO2 (100% or 50%), appropriate ventilatory mode (manual or pressure support ventilation), and proper end-expiratory pressure (zero or preserved end-expiratory pressure), and noting deviations, with adherence defined as successful performance of all criteria during extubation.
Time frame: At the end of surgery for individual assessments. At the end of the study (average 9 months) at the study level.
Postoperative pulmonary complications outcome completion rate
Postoperative pulmonary complications are defined as a composite endpoint that includes atelectasis, pneumonia, acute respiratory distress syndrome, and pulmonary aspiration, according to the StEP-COMPAC definition.
Time frame: At postoperative day 7 for individual assessments. At the end of the study (average 9 months) at the study level.
Accuracy of self-reported protocol adherence compared to directly observed protocol adherence
Following emergence from general anesthesia, treating anesthesiologists will complete the same four-point scoring sheet as the research assistant to self-report protocol adherence.
Time frame: At the end of the surgery
Postoperative pulmonary complications
Postoperative pulmonary complications are defined as a composite endpoint that includes atelectasis, pneumonia, acute respiratory distress syndrome, and pulmonary aspiration, according to the StEP-COMPAC definition.
Time frame: At postoperative day 7
Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit
Obtained from the electronic medical record or the handwritten vital signs sheet. Calculated as %.h-1
Time frame: At postoperative day 7 or hospital discharge (earliest of the two)
Quality of recovery
Evaluated using the QoR-15 questionnaire completed at the bedside.
Time frame: At postoperative day 1
Discharge disposition
Location to which patient is discharged (e.g., home, long term care facility, etc.) Assessed during telephone interview and using administrative data. We will
Time frame: At postoperative day 30
Days alive and out of hospital
Assessed during telephone interview and using administrative data
Time frame: At postoperative day 30
Health-related quality of life
Evaluated using the EQ-5D-5L questionnaire completed during a telephone interview
Time frame: At postoperative day 90
Lowest oxygen saturation post-extubation in the operating room
Lowest SpO2 in the operating room during emergence
Time frame: At operating room exit
Time in minutes with oxygen saturation < 85% post-extubation in the operating room
Time with SpO2 \< 85% in the operating room during emergence
Time frame: At operating room exit
Re-intubation rate in the operating room and in the post-anesthesia care unit
Re-intubation in the operating room during emergence or in the post-anesthesia care unit
Time frame: At discharge from the post-anesthesia care unit
Plan to share: No — End-of-grant knowledge translation modalities will be used to reach other important stakeholders, researchers and members of the anesthesia community: scientific meetings, open access publication in a Canadian journal, and public presentations with patient partners. Knowledge diffusion on potential difficulties of conducting such trials (and solutions) will be transferred to the research community through meetings of the Canadian Perioperative Anesthesia Clinical Trial group (PACT). A methodological meeting will be organized with participating sites of both pilot and future efficacy phases to enhance protocol applicability before going forward to the efficacy phase. This plan will help recruit more Canadian centres for the efficacy trial and conduct the intervention in these centres.
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Dec 2026, 25 months after the start.
Of 40 interventional studies with no phase under Ventilator-Induced Lung Injury, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 25 months is below that.
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